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Date:

Subject:

October 5, 2010

510(k) Summary of Safety and Effectiveness Information for the NeuWave Medical Certus 140 2.45 GHz Ablation System and Accessories NeuWave Medical, Inc. 3529 Anderson Street Madison, WI 53704 TBD Dan Kosednar, Director of Regulatory Affairs and Quality Assurance P - 608-512-1592 F- 608-512-1509 Certus 140 2.45 GHz Ablation System and Accessories System, Ablation, Microwave and Accessories General and Plastic Surgery, 73 NEY, 21 CFR 878.4440

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Company:

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FDA Establishment# Contact:

Proprietary: Common: Classification:

The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMVDA 1990 and 1992. Predicate Devices The Certus 140 2.45 GHz Ablation System and Accessories issubstantially equivalent to the following currently marketed device: * * ValleyLab Microwave Ablation Generator - Class II - 21CFRS7S.4400, which has been the subject of a cleared 510(k) with FDA log number 072687 and K053535. ValleyLab Cool-Tip RF Generator, Cool-Tip RF System and Accessories - Class II 21CFR878.4400, which has been the subject of a cleared 510(k) with FDA log number K(052796 and K(053290. EndloCare CryoCare Surgical System, Model Cryo 20 - Class II - 21CFR878.4350, which has been the subject of a cleared 510(k) with FDA log number K023757.

Microsurgeon Microwave Tissue Ablation Device - Class 11- 21CFR878.4400, which has been the subject of a cleared 510(k) with FDA log number 070023 Boston Scientific RF 3000Generator - Class 11- 21CFR878.4400, which has been the subject of a cleared 510(k) with FDA log number K000241

*

* *

Intended Use The NeuWave Medical Certus 140 2.45 GI-z Ablation System and Accessories are intended for the

ablation (coagulation) of soft tissue. The Certus 140 2.45 GHz Ablation System is not intended for use in cardiac procedures.

Certus 140 510(k) Submission Safety Summary Page 1 of 3

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NeuWave recommends against the use of the Certus 140 2.45 GHz Ablation System in the following situations: * Pregnant patients - potential risks to patient and/or fetus have not been established * Patients with implantable pacemakers or other electronic implants. Implanted electronic devices may be adver sely affected by microwave power

The system isdesigned for facility use and should only be used under the orders of a clinician. Device Description The system has three (3) independent 2.45 GHz microwave generators, each capable of producing up to 140W each. One, easy to use, touch-screen user interface controls the system. Up to 3 microwave ablation probes can be connected to and powered by the system at one time. The maximum selectable power for the system is 140W when one probe isconnected, 95Wper probe when 2 probes are connected and 65W per probe when 3 probes are connected. An intermediate junction box or Power Distribution Module (PDMV) reduces system set up complexity. Probes are provided sterile and are intended for single patient use only. Probes are available for both percutaeous and open surgical applications. Percutaneous probes are comprised of 17 gauge needles, a probe handle, a 1.4M cable and a connector assembly. Percutaneous probes are available in Certus and Certus I. Certus 1Kprobes are designed to perform optimally, in terms of efficiently transferring energy into tissue, in liver and kidney tissue. Certus 140LIN probes are designed to perform optimally, in terms of efficiently transferring energy into tissue, in lung tissue. All percutaeous probes are available in 15cm and 20 cm lengths. The open surgical probe, Certus

S,

is 13 gauge and available in a 25cm length.

All probes have temperature sensing thermocouples at various places along the shaft to monitor the probe temperature. A CO, based cooling system ensures the non-active portion of the probe does not exceed temperature requirements. Additionally, the CO enables the Tissu-Loc function, which can be used to adhere or stick 2 the probe in place prior to starting ablation therapy. This function is similar in use to the stick function available on cryogenic ablation systems. The system uses two (2) F-sized CO, cylinders. When a tank inuse empties, the system will automatically switch to using the other tank and notify the user to replace the empty tank.

Performance Data

The Certus 140 2.45 GHz Ablation System and Accessories has been designed to comply with the applicable portions of various International Standards, including: * * * * * * UL 60601-1:2003 IEC 60601-1:1988 Plus Amendments IEC 60601-2-2:2006 IEC 60601-2-6:1984 IEC 60601-1-2:2007 EN ISO 11607-1:2006

Certus 140 510(k) Submission Safety Summary Page 2 of 3

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*ISO 10993-1: 2003 The Certus 140 2.45 GHz Ablation System and Accessories and the predicate devices are substantially equivalent in design concepts, technologies and materials. The Certus 140 Ablation 2.45 GHz System and Accessories has been verified through rigorous testing that, in part, supports the compliance of Certus 140 2.45 GHz Ablation System and Accessories to the standards listed above. Ex-vivo studies were conducted to compare the performance of the Certus 140 2.45 GHz Ablation System and Accessories to a predicate device.

Certus 140 510(k) Submission Safety Summary Page 3 of 3

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DEPARTMENT OF HEALTH & HUMAN SERVICES ~

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Public Health Service

and Dr Adminrii ~~~~~~~~~~~~~~~~~~~~~~~ ion 10903 New Hanipshire Avenue Document Control Roomn -W066-G609 Silver Spring, MD 20993-0002

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Neu Wave Medical, Inc. % Mr. Daniel Kosednar 3529 Anderson Street Madison, Wisconsin 53704

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222010

Re: K]00744 Trade Name: Certus 140 2.45 GHz Ablation System and Accessories Regulation Number: 21 CER 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NEY, GEL Dated: October 6, 201 0 Received: October 7, 201 0 Dear Mr. Kosednar: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Ding, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labelingand prohibitions against misbranding and adulteration. Please note: CDRLH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be tmuthffil and not misleading. If your device is classified (see above) into either class II (Special Controls) or class HII (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 2 1, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

Page 2 - Mr. Daniel Kosednar

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 53 1-542 of the Act); 21 CER 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CER Part 801), please go to lhttp://w~ww.fda.gov/AboutFDA/CenitersOffices/CDPJ-y/CDRHq~ffices/'ucin 115 809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CER Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http:!/www.fda.gov/MedicalDevices/Safety/ReportaProblem/default~htini for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address h-ttp://www.fda.giiov/MedicalDevices/ResourcesforYou/lndustry/default.htm. Sincerely yours,

MakMelkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation* Center for DeVices and Radiological Health

Indications for Use

510(k) Number (if known): K

Kt 2( 00 7 qt OCT 22010

Device Name: Certus 140 2.45 GHz Ablation System and Accessories Indications For Use:

The NeuWave Medical Certus 140 2.45 0Hz Ablation System and Accessories are intended for the ablation (coagulation) of soft tissue. The Gertus 140 2.45 GHz Ablation System is not intended for use in cardiac procedures. NeuWave recommends against the use of the Certus 140 2.45 0Hz Ablation System in the following situations: * Pregnant patients - potential risks to patient and/or fetus have not been established * Patients with implantable pacemakers or other electronic implants. Implanted electronic devices may be adversely affected by microwave power The system is designed for facility use and should only be used under the orders of a clinician.

Prescription Use XXX

AND/OR

Over-The-Counter Use

(21 CFR 807 Subpart C)

_

__

(Part 21 GFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Pagel1of -1

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